Effect of Combination of Mitiglinide and Metformin on Glycemic Control in Patients With Type 2 Diabetes Mellitus

Phase 3 Study of Combination of Mitiglinide and Metformin in Patients With Type 2 Diabetes Mellitus

We performed a prospective, randomized, multicenter trial to assess the efficacy and safety of combined treatment with mitiglinide and metformin for patients with type 2 diabetes who show inadequate glycemic control with metformin monotherapy. Subjects with HbA1c >7.0% after an 8-week metformin run-in phase were randomized to a 16-week trial phase with metformin plus mitiglinide (Met+Mit) or metformin plus placebo (Met).

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Mitiglinide; Drug: Placebo

Detailed Description

This was a 16-week, randomized, double-blind study for comparing metformin plus mitiglinide (Met+Mit) versus metformin plus placebo (Met+Pcb). An 8-week metformin run-in phase (500 mg twice a day for the first 4 weeks and 500 mg three times a day for the following 4 weeks) was followed by a 16-week trial phase (mitiglinide 10 mg or placebo three times a day added to metformin 500 mg three times a day). The subjects with an HbA1c >7.0% at the end of the metformin run-in phase were randomized to a Met+Mit group or a Met+Pcb group of the trial phase.

• Study Type: Interventional
• Enrollment (Actual): 145
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Pusan National University College of Medicine
  • Daegu, Korea, Republic of
    • Kyungpook National University School of Medicine
  • Daejeon, Korea, Republic of
    • Chungnam National University College of Medicine
  • Gwangju, Korea, Republic of
    • Chonnam National University College of Medicine
  • Jeonju, Korea, Republic of
    • Chonbuk National University College of Medicine
  • Seoul, Korea, Republic of
    • Seoul St. Mary's Hospital
  • Seoul, Korea, Republic of
    • Korea University College of Medicine
  • Seoul, Korea, Republic of
    • Yonsei University College of Medicine
  • Seoul, Korea, Republic of
    • The Catholic University of Korea
  • Seoul, Korea, Republic of
    • Eulji University School of Medicine
  • Seoul, Korea, Republic of
    • Hallym University College of Medicine
  • Seoul, Korea, Republic of
    • SungKyunKwan University School of Medicine
  • Uijeongbu, Korea, Republic of
    • Uijeongbu St. Mary Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• aged 30-70 years
• had a duration of diabetes of <10 years
• body mass index (BMI) 20-35 kg/m2
• a plasma HbA1c level of 7.5-11% during the previous 4 weeks

Exclusion Criteria:

• subjects who were diagnosed with type 1 diabetes, gestational diabetes, or diabetes with any specific causes
• Subjects who had been treated with nateglinide, repaglinide, metformin (over 1,000 mg/day), or sulfonylurea (over a quarter of the maximum recommended dose) during the previous 8 weeks

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Metformin+Mitiglinide; mitiglinide 10 mg three times a day added to metformin 500 mg three times a day	Drug: Mitiglinide; mitiglinide 10 mg three times a day added to metformin 500 mg three times a day for 16 weeks
Placebo Comparator: Metformin+Placebo; placebo three times a day added to metformin 500 mg three times a day	Drug: Placebo; placebo three times a day added to metformin 500 mg three times a day for 16 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the change in HbA1c from randomization to endpoint	16 weeks after radomization

Secondary Outcome Measures

Outcome Measure	Time Frame
the proportion of subjects with HbA1c <7% after 16 weeks of treatment and the change in FPG and 2-hr postprandial glucose (PPG) from baseline	16 weeks after radomization

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Seoul St. Mary's Hospital; Korea University; Yonsei University; Kyungpook National University Hospital; The Catholic University of Korea; Hallym University; Chungnam National University; Uijeongbu St. Mary Hospital; Chonnam National University; Chonbuk National University; Eulji University; Sungkyunkwan University; Pusan National University College of Medicine

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: December 19, 2009
• First Submitted That Met QC Criteria: December 19, 2009
• First Posted (Estimate): December 23, 2009

Study Record Updates

• Last Update Posted (Estimate): December 23, 2009
• Last Update Submitted That Met QC Criteria: December 19, 2009
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Mitiglinide
• Other Study ID Numbers: IMMEDIATE